Myofacial PainPhase 2/3MPS MTrPs BTANCT06676475
Comparison Between Botox and Magnesium Sulfate Effect in Treatment of Myofascial Pain Trigger Points Within the Masseter Muscle
A Phase 2/3 study testing MgSO4 and BOTOX-A in people with Myofacial Pain and Trigger Points, Myofascial, run by Misr University for Science and Technology at 1 site in Egypt.
Trial summary
The goal of this randomized clinical trial is to compare the effectiveness of Botulinum toxin type A, magnesium sulfate and saline injections in treatment of the masseter muscle trigger points, in patients between 16 - 50 years old with myofascial pain with masseter muscle trigger points. Read more about this study
- Who is it for?
- Ages 16 to 50 years
- Conditions the study is for
- Myofacial Pain, Trigger Points, Myofascial
- What is being tested?
- MgSO4 and BOTOX-A
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2024to Aug 2025
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 50 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients diagnosed with orofacial pain and trigger points in the masseter muscle unilaterally or bilaterally for at least period 6 months other criteria
- Definite diagnosis of myofascial pain based on the DC/TMD criteria with a referral
- Presence of one or more unilateral or bilateral trigger points in the masseter muscle
- No history of any invasive procedures of the related masseter muscle (Taşkesen, Cezairli, 2023.)
Who cannot join
- Any painful conditions (other than myofascial trigger points) affecting the orofacial region
- Any systemic diseases that could affect masticatory function (e.g., rheumatoid arthritis and epilepsy
- Pregnancy and lactation. (Refahee, Mahrous, Shabaan,2022)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
Misr university for science and technology
Giza
Mayada Tarek El Menoufy, +2001009006845, mayadatarek@hotmail.com
About this study
Official title: Comparison of the Effectiveness of Botulinum Toxin and Magnesium Sulfate Injections in the Treatment of Myofascial Trigger Points in the Masseter Muscle Randomized Controlled Clinical Trial
The goal of this randomized clinical trial is to compare the effectiveness of Botulinum toxin type A, magnesium sulfate and saline injections in treatment of the masseter muscle trigger points, in patients between 16 - 50 years old with myofascial pain with masseter muscle trigger points. The main questions it aims to answer are:
- which treatment has longer effect of pain release with the least possible side effects and recurrence rate?
- Which treatment has greater impact on improving patient's quality of life? Researchers will compare Botulinum toxin type A, magnesium sulfate to a placebo saline injections in treatment of the masseter muscle trigger points Participants will attend to the clinic 4 times
- 1st visit will include taking preoperative records and treatment injection
- 2nd visit will be follow up and taking records after 1 month
- 3rd visit will be follow up and taking records after 3 months
- 4th visit will be follow up and taking records after 6 months
Read the detailed description
Myofascial pain syndrome (MPS) is common syndrome in patients with musculoskeletal pain problems. It's a pain condition originating from muscle and surrounding fascia. Patient usually complains from localized pain in a certain area or referred pain of various patterns. On physical examinations, trigger points (TrPs) may reveal on the involved muscles. (Tantanatip, Chang,2018). TrPs are usually palpable and hyperirritable nodule found within a taut band of muscle. By Stimulating these points, two characteristic phenomena are produced: sudden contractions of the taut band and referred pain, which is known as the local twitch response (LTR). Active MTrPs usually produce pain spontaneously, and sometimes referred pain, while Latent MTrPs produce referred pain in response to the applied pressure, but not spontaneously (Simons, D.G, 2004).
Multiple factors can contribute to MPS. The risk factors are; Traumatic events, ergonomic factors (e.g., overuse activities, abnormal posture, Structural factors (e.g., spondylosis, scoliosis, osteoarthritis), systemic factors (e.g., hypothyroidism, vitamin D deficiency, iron deficiency). (Saxena,et al,2015), however Intramuscular injections are considered the first-line treatment for myofascial TrPs(Yilmaz, et al 2021). Injections could be wet as local anesthetic agents, steroid, platelet rich plasma, saline or botulinum toxin, or it could be dry by dry needling without solutions MPS is a result of inappropriate activity of acetylcholine (ACh) at the neuromuscular junction, producing a sustained contraction of the sarcomere. The ACh-related effects are relevant to the taut band development, which leads to increasing the local energy demand or energy crisis (Simons, D.G, 2004). The pain in the local muscle occurs secondary to the substances released from the damaged muscle, and from the extracellular fluid around the TrP, such as protons (H+) on acid-sensing ion channels which occurs in ischemia and in exercise. In these metabolic conditions, sensitizing amines may be released stimulating the nociceptors and giving rise to pain. Therefore, MTrPs are better defined by two phenomena: altered ACh activity and nociceptive stimulation (Sluka, Kalra, Moore,2001). The fact of myofascial muscles are a part of the stomatognathic system, any imbalance in this system could have a disturbing impact on its function such as mastication, posture and non-physiological occlusion, affecting the patient's quality of life (Fiorillo, 2020).
Botulinum toxin type A is a neurotoxin used to reduce excessive muscle contraction. Its produced by gram-positive, anaerobic, spore-forming bacilli known as Clostridium botulinum which is widely distributed in aquatic and soil environments. (Tiwari,Nagalli 2024). Botulinum toxin inhibits neurotransmission at the neuromuscular junction. Several transport proteins participate in the process by which ACh is released; these proteins aggregate to form the SNARE complex (Soluble NSF (N-Ethylmaleimide-Sensitive Factor) Attachment Protein Receptor, responsible for fusion of the vesicles of ACh with the membrane and the subsequent release of the neurotransmitter. The heavy chain of the toxin has a high affinity for the membrane receptors and, once bound, BTA undergoes endocytosis. The light chain is released within the cell, where it acts as a zinc-dependent endoprotease. After cleavage of one of the proteins of the SNARE complex by BTA, the complex does not form and ACh is not released. (Aikawa,et al , 2006) Magnesium sulfate (MgSO4) is commonly used as analgesics for treatment of musculoskeletal problems, snice having muscle relaxant and vasodilator properties. (Ibrahim, Raoof, Mosaad,2021). These properties can likely be attributed to its ability to block presynaptic acetylcholine discharge from neuromuscular and sympathetic junctions (Dahle, et al ,1995). Therefore, MgSo4 injections are an effective treatment modality for myofascial TrPs of the masseter muscle. It helps in reducing the pain and improving the maximum mouth opening, in addition to the quality of patient's life. (Refahee, Mahrous, Shabaan,2022)
Intervention After the MTP is located and the overlying skin had been disinfected with alcohol, the taut muscle band is pinched between the thumb and index finger, and the needle is inserted 1-2 cm away from the targeted MTP at an angle of 30º to the skin. A negative aspiration should be performed to prevent any intravascular injections (Taşkesen, Cezairli, 2023). Group 1: 2ml MgSo4 (Magnesium sulfate sterile ampoule 10 ml, 100 mg/ml = 0.41 mMol/ml. Egyptian Int. Pharmaceutical Industries Co., Egypt). Group 2: 2ml of BTX and Group 3: 2 ml of saline
- Conditions
- Myofacial Pain, Trigger Points, Myofascial
- Being tested
- MgSO4, BOTOX-A, Saline (NaCl 0,9 %) (placebo)
- Keywords
- myofascial pain, masseter trigger point, MPS, MTrPs, MgSO4 in myofascial trigger points, BTA in myofascial trigger points, Botox in masseter trigger points, magnesium sulfate in masseter trigger points
- Medical subject headings
- Facial Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MgSO4Drug
2ml MgSo4 (Magnesium sulfate sterile ampoule 10 ml, 100 mg/ml = 0.41 mMol/ml. Egyptian Int. Pharmaceutical Industries Co., Egypt).
BOTOX-ADrug
2ml of BTX
Saline (NaCl 0,9 %) (placebo)Drug
2 ml of saline
| Study group | Role | What they receive |
|---|---|---|
| Group I: Patients will receive Magnesium Sulfate injection into trigger points | Experimental | Not described Receives: Drug: MgSO4 |
| Group II: Patients will receive Botulinum Toxin into trigger points | Active comparator | Not described Receives: Drug: BOTOX-A |
| Group III: Patients will receive Saline injection into trigger points | Placebo comparator | Not described Receives: Drug: Saline (NaCl 0,9 %) (placebo) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluating pain
Pain will be recorded with a visual analog scale (VAS of 0-10, with zero being no pain and 10 the worst pain possible)
Measured: preoperative - post operative - 1 , 3 ,6 months follow up
Secondary outcomes (3)
Pain-free maximum mouth opening (MMO)
Pain-free MMO will be measured as the distance between the incisal edges of the upper and lower incisors. Three measurements will be performed, and their average was recorded (Taşkesen, Cezairli, 2023).
Measured: preoperative - post operative - 1 , 3 ,6 months follow up
Muscle health and activity measured using electromyography
Muscle health and activity measured using electromyography, EMG can provide valuable insights into altered muscle activity patterns and help in the diagnosis and management of MPDS through readings (Zieliński, et al, 2021).
Measured: preoperative - post operative - 1 , 3 ,6 months follow up
The quality of life will be assessed using the Oral Health Impact Profile questionnaire (OHIP-14)
The quality of life will be assessed using the Oral Health Impact Profile questionnaire (OHIP-14) containing 14 questions divided into seven domains of oral health. The participant will be asked to score each question using a scale from 1 to 5 [never (score 0); hardly ever (score 1); occasionally (score 2); fairly often (score 3); and very often (score 4)], and the sum of all 14 items was calculated. The OHIP score could range from 0 to 56 units, with the former indicating no problems and higher scores representing greater impairment of quality of life (Slade and Spencer, 1994).
Measured: preoperative - post operative - 1 , 3 ,6 months follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2024
- Study start1 Dec 2024 (estimated)
- Primary completionFeb 2025 (estimated)
- Study completionAug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Myofacial PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Misr University for Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mayada tarek, Misr University for Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06676475
- Sponsor's protocol ID
- 200036178
- Acronym
- MPS MTrPs BTA
- Status last verified
- Nov 2024
- First submitted
- 4 Nov 2024
- Last updated
- 12 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Zielinski G, Bys A, Szkutnik J, Majcher P, Ginszt M. Electromyographic Patterns of Masticatory Muscles in Relation to Active Myofascial Trigger Points of the Upper Trapezius and Temporomandibular Disorders. Diagnostics (Basel). 2021 Mar 24;11(4):580. doi: 10.3390/diagnostics11040580.
PubMed 33805008Yilmaz O, Sivrikaya EC, Taskesen F, Pirpir C, Ciftci S. Comparison of the Efficacy of Botulinum Toxin, Local Anesthesia, and Platelet-Rich Plasma Injections in Patients With Myofascial Trigger Points in the Masseter Muscle. J Oral Maxillofac Surg. 2021 Jan;79(1):88.e1-88.e9. doi: 10.1016/j.joms.2020.09.013. Epub 2020 Sep 14.
PubMed 33045182Taskesen F, Cezairli B. The effectiveness of the masseteric nerve block compared with trigger point injections and dry needling in myofascial pain. Cranio. 2023 Mar;41(2):96-101. doi: 10.1080/08869634.2020.1820686. Epub 2020 Sep 16.
PubMed 32935643Tantanatip, A. and Chang, K.V., 2018. Myofascial pain syndrome.
Sluka KA, Kalra A, Moore SA. Unilateral intramuscular injections of acidic saline produce a bilateral, long-lasting hyperalgesia. Muscle Nerve. 2001 Jan;24(1):37-46. doi: 10.1002/1097-4598(200101)24:13.0.co;2-8.
PubMed 11150964Slade GD, Spencer AJ. Development and evaluation of the Oral Health Impact Profile. Community Dent Health. 1994 Mar;11(1):3-11.
PubMed 8193981Simons DG. Review of enigmatic MTrPs as a common cause of enigmatic musculoskeletal pain and dysfunction. J Electromyogr Kinesiol. 2004 Feb;14(1):95-107. doi: 10.1016/j.jelekin.2003.09.018.
PubMed 14759755Saxena A, Chansoria M, Tomar G, Kumar A. Myofascial pain syndrome: an overview. J Pain Palliat Care Pharmacother. 2015 Mar;29(1):16-21. doi: 10.3109/15360288.2014.997853. Epub 2015 Jan 5.
PubMed 25558924Refahee SM, Mahrous AI, Shabaan AA. Clinical efficacy of magnesium sulfate injection in the treatment of masseter muscle trigger points: a randomized clinical study. BMC Oral Health. 2022 Sep 19;22(1):408. doi: 10.1186/s12903-022-02452-3.
PubMed 36123724Pihut M, Ferendiuk E, Szewczyk M, Kasprzyk K, Wieckiewicz M. The efficiency of botulinum toxin type A for the treatment of masseter muscle pain in patients with temporomandibular joint dysfunction and tension-type headache. J Headache Pain. 2016;17:29. doi: 10.1186/s10194-016-0621-1. Epub 2016 Mar 24.
PubMed 27011213Nitecka-Buchta A, Walczynska-Dragon K, Batko-Kapustecka J, Wieckiewicz M. Comparison between Collagen and Lidocaine Intramuscular Injections in Terms of Their Efficiency in Decreasing Myofascial Pain within Masseter Muscles: A Randomized, Single-Blind Controlled Trial. Pain Res Manag. 2018 Jun 3;2018:8261090. doi: 10.1155/2018/8261090. eCollection 2018.
PubMed 29973970Ibrahim NA, Abdel Raoof NA, Mosaad DM, Abu El Kasem ST. Effect of magnesium sulfate iontophoresis on myofascial trigger points in the upper fibres of the trapezius. J Taibah Univ Med Sci. 2021 Jan 19;16(3):369-378. doi: 10.1016/j.jtumed.2020.12.015. eCollection 2021 Jun.
PubMed 34140864Fiorillo L. Spine and TMJ: A Pathophysiology Report. J Funct Morphol Kinesiol. 2020 Mar 30;5(2):24. doi: 10.3390/jfmk5020024.
PubMed 33467240Dahle LO, Berg G, Hammar M, Hurtig M, Larsson L. The effect of oral magnesium substitution on pregnancy-induced leg cramps. Am J Obstet Gynecol. 1995 Jul;173(1):175-80. doi: 10.1016/0002-9378(95)90186-8.
PubMed 7631676Blanco-Rueda JA, Lopez-Valverde A, Marquez-Vera A, Mendez-Sanchez R, Lopez-Garcia E, Lopez-Valverde N. Preliminary Findings of the Efficacy of Botulinum Toxin in Temporomandibular Disorders: Uncontrolled Pilot Study. Life (Basel). 2023 Jan 28;13(2):345. doi: 10.3390/life13020345.
PubMed 36836702
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effectiveness of Botulinum Toxin and Magnesium Sulfate Injections in the Treatment of Myofascial Trigger Points in the Masseter Muscle Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT06676475
- Acronym / sponsor ID
- MPS MTrPs BTA / 200036178
- Conditions
- Myofacial Pain, Trigger Points, Myofascial
- Keywords
- myofascial pain, masseter trigger point, MPS, MTrPs, MgSO4 in myofascial trigger points, BTA in myofascial trigger points, Botox in masseter trigger points, magnesium sulfate in masseter trigger points
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Misr University for Science and TechnologyUniversity, hospital or other
- Study start
- 1 Dec 2024 (estimated)
- Primary completion
- Feb 2025 (estimated)
- Study completion
- Aug 2025 (estimated)
- First posted
- 6 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this randomized clinical trial is to compare the effectiveness of Botulinum toxin type A, magnesium sulfate and saline injections in treatment of the masseter muscle trigger points, in patients between 16 - 50 years old with myofascial pain with masseter muscle trigger points. The main questions it aims to answer are:
- which treatment has longer effect of pain release with the least possible side effects and recurrence rate?
- Which treatment has greater impact on improving patient's quality of life? Researchers will compare Botulinum toxin type A, magnesium sulfate to a placebo saline injections in treatment of the masseter muscle trigger points Participants will attend to the clinic 4 times
- 1st visit will include taking preoperative records and treatment injection
- 2nd visit will be follow up and taking records after 1 month
- 3rd visit will be follow up and taking records after 3 months
- 4th visit will be follow up and taking records after 6 months
Detailed description
Myofascial pain syndrome (MPS) is common syndrome in patients with musculoskeletal pain problems. It's a pain condition originating from muscle and surrounding fascia. Patient usually complains from localized pain in a certain area or referred pain of various patterns. On physical examinations, trigger points (TrPs) may reveal on the involved muscles. (Tantanatip, Chang,2018). TrPs are usually palpable and hyperirritable nodule found within a taut band of muscle. By Stimulating these points, two characteristic phenomena are produced: sudden contractions of the taut band and referred pain, which is known as the local twitch response (LTR). Active MTrPs usually produce pain spontaneously, and sometimes referred pain, while Latent MTrPs produce referred pain in response to the applied pressure, but not spontaneously (Simons, D.G, 2004).
Multiple factors can contribute to MPS. The risk factors are; Traumatic events, ergonomic factors (e.g., overuse activities, abnormal posture, Structural factors (e.g., spondylosis, scoliosis, osteoarthritis), systemic factors (e.g., hypothyroidism, vitamin D deficiency, iron deficiency). (Saxena,et al,2015), however Intramuscular injections are considered the first-line treatment for myofascial TrPs(Yilmaz, et al 2021). Injections could be wet as local anesthetic agents, steroid, platelet rich plasma, saline or botulinum toxin, or it could be dry by dry needling without solutions MPS is a result of inappropriate activity of acetylcholine (ACh) at the neuromuscular junction, producing a sustained contraction of the sarcomere. The ACh-related effects are relevant to the taut band development, which leads to increasing the local energy demand or energy crisis (Simons, D.G, 2004). The pain in the local muscle occurs secondary to the substances released from the damaged muscle, and from the extracellular fluid around the TrP, such as protons (H+) on acid-sensing ion channels which occurs in ischemia and in exercise. In these metabolic conditions, sensitizing amines may be released stimulating the nociceptors and giving rise to pain. Therefore, MTrPs are better defined by two phenomena: altered ACh activity and nociceptive stimulation (Sluka, Kalra, Moore,2001). The fact of myofascial muscles are a part of the stomatognathic system, any imbalance in this system could have a disturbing impact on its function such as mastication, posture and non-physiological occlusion, affecting the patient's quality of life (Fiorillo, 2020).
Botulinum toxin type A is a neurotoxin used to reduce excessive muscle contraction. Its produced by gram-positive, anaerobic, spore-forming bacilli known as Clostridium botulinum which is widely distributed in aquatic and soil environments. (Tiwari,Nagalli 2024). Botulinum toxin inhibits neurotransmission at the neuromuscular junction. Several transport proteins participate in the process by which ACh is released; these proteins aggregate to form the SNARE complex (Soluble NSF (N-Ethylmaleimide-Sensitive Factor) Attachment Protein Receptor, responsible for fusion of the vesicles of ACh with the membrane and the subsequent release of the neurotransmitter. The heavy chain of the toxin has a high affinity for the membrane receptors and, once bound, BTA undergoes endocytosis. The light chain is released within the cell, where it acts as a zinc-dependent endoprotease. After cleavage of one of the proteins of the SNARE complex by BTA, the complex does not form and ACh is not released. (Aikawa,et al , 2006) Magnesium sulfate (MgSO4) is commonly used as analgesics for treatment of musculoskeletal problems, snice having muscle relaxant and vasodilator properties. (Ibrahim, Raoof, Mosaad,2021). These properties can likely be attributed to its ability to block presynaptic acetylcholine discharge from neuromuscular and sympathetic junctions (Dahle, et al ,1995). Therefore, MgSo4 injections are an effective treatment modality for myofascial TrPs of the masseter muscle. It helps in reducing the pain and improving the maximum mouth opening, in addition to the quality of patient's life. (Refahee, Mahrous, Shabaan,2022)
Intervention After the MTP is located and the overlying skin had been disinfected with alcohol, the taut muscle band is pinched between the thumb and index finger, and the needle is inserted 1-2 cm away from the targeted MTP at an angle of 30º to the skin. A negative aspiration should be performed to prevent any intravascular injections (Taşkesen, Cezairli, 2023). Group 1: 2ml MgSo4 (Magnesium sulfate sterile ampoule 10 ml, 100 mg/ml = 0.41 mMol/ml. Egyptian Int. Pharmaceutical Industries Co., Egypt). Group 2: 2ml of BTX and Group 3: 2 ml of saline
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group I: Patients will receive Magnesium Sulfate injection into trigger points | Experimental | Drug: MgSO4 |
| Group II: Patients will receive Botulinum Toxin into trigger points | Active comparator | Drug: BOTOX-A |
| Group III: Patients will receive Saline injection into trigger points | Placebo comparator | Drug: Saline (NaCl 0,9 %) (placebo) |
Who may qualify
- Ages
- 16 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Patients diagnosed with orofacial pain and trigger points in the masseter muscle unilaterally or bilaterally for at least period 6 months other criteria
- Definite diagnosis of myofascial pain based on the DC/TMD criteria with a referral
- Presence of one or more unilateral or bilateral trigger points in the masseter muscle
- No history of any invasive procedures of the related masseter muscle (Taşkesen, Cezairli, 2023.)
Key exclusion criteria (3 listed)
- Any painful conditions (other than myofascial trigger points) affecting the orofacial region
- Any systemic diseases that could affect masticatory function (e.g., rheumatoid arthritis and epilepsy
- Pregnancy and lactation. (Refahee, Mahrous, Shabaan,2022)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MgSO42ml MgSo4 (Magnesium sulfate sterile ampoule 10 ml, 100 mg/ml = 0.41 mMol/ml. Egyptian Int. Pharmaceutical Industries Co., Egypt). | Drug | Group I: Patients will receive Magnesium Sulfate injection into trigger points |
| BOTOX-A2ml of BTX | Drug | Group II: Patients will receive Botulinum Toxin into trigger points |
| Saline (NaCl 0,9 %) (placebo)2 ml of saline | Drug | Group III: Patients will receive Saline injection into trigger points |
Primary outcome
Evaluating pain
Time frame: preoperative - post operative - 1 , 3 ,6 months follow up
Pain will be recorded with a visual analog scale (VAS of 0-10, with zero being no pain and 10 the worst pain possible)
3 secondary outcomes
Pain-free maximum mouth opening (MMO)
Time frame: preoperative - post operative - 1 , 3 ,6 months follow up
Muscle health and activity measured using electromyography
Time frame: preoperative - post operative - 1 , 3 ,6 months follow up
The quality of life will be assessed using the Oral Health Impact Profile questionnaire (OHIP-14)
Time frame: preoperative - post operative - 1 , 3 ,6 months follow up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2024.
- Background: PubMed 33805008Zielinski G, Bys A, Szkutnik J, Majcher P, Ginszt M. Electromyographic Patterns of Masticatory Muscles in Relation to Active Myofascial Trigger Points of the Upper Trapezius and Temporomandibular Disorders. Diagnostics (Basel). 2021 Mar 24;11(4):580. doi: 10.3390/diagnostics11040580.
- Background: PubMed 33045182Yilmaz O, Sivrikaya EC, Taskesen F, Pirpir C, Ciftci S. Comparison of the Efficacy of Botulinum Toxin, Local Anesthesia, and Platelet-Rich Plasma Injections in Patients With Myofascial Trigger Points in the Masseter Muscle. J Oral Maxillofac Surg. 2021 Jan;79(1):88.e1-88.e9. doi: 10.1016/j.joms.2020.09.013. Epub 2020 Sep 14.
- Background: PubMed 32935643Taskesen F, Cezairli B. The effectiveness of the masseteric nerve block compared with trigger point injections and dry needling in myofascial pain. Cranio. 2023 Mar;41(2):96-101. doi: 10.1080/08869634.2020.1820686. Epub 2020 Sep 16.
- BackgroundTantanatip, A. and Chang, K.V., 2018. Myofascial pain syndrome.
- Background: PubMed 11150964Sluka KA, Kalra A, Moore SA. Unilateral intramuscular injections of acidic saline produce a bilateral, long-lasting hyperalgesia. Muscle Nerve. 2001 Jan;24(1):37-46. doi: 10.1002/1097-4598(200101)24:13.0.co;2-8.
- Background: PubMed 8193981Slade GD, Spencer AJ. Development and evaluation of the Oral Health Impact Profile. Community Dent Health. 1994 Mar;11(1):3-11.
- Background: PubMed 14759755Simons DG. Review of enigmatic MTrPs as a common cause of enigmatic musculoskeletal pain and dysfunction. J Electromyogr Kinesiol. 2004 Feb;14(1):95-107. doi: 10.1016/j.jelekin.2003.09.018.
- Background: PubMed 25558924Saxena A, Chansoria M, Tomar G, Kumar A. Myofascial pain syndrome: an overview. J Pain Palliat Care Pharmacother. 2015 Mar;29(1):16-21. doi: 10.3109/15360288.2014.997853. Epub 2015 Jan 5.
- Background: PubMed 36123724Refahee SM, Mahrous AI, Shabaan AA. Clinical efficacy of magnesium sulfate injection in the treatment of masseter muscle trigger points: a randomized clinical study. BMC Oral Health. 2022 Sep 19;22(1):408. doi: 10.1186/s12903-022-02452-3.
- Background: PubMed 27011213Pihut M, Ferendiuk E, Szewczyk M, Kasprzyk K, Wieckiewicz M. The efficiency of botulinum toxin type A for the treatment of masseter muscle pain in patients with temporomandibular joint dysfunction and tension-type headache. J Headache Pain. 2016;17:29. doi: 10.1186/s10194-016-0621-1. Epub 2016 Mar 24.
- Background: PubMed 29973970Nitecka-Buchta A, Walczynska-Dragon K, Batko-Kapustecka J, Wieckiewicz M. Comparison between Collagen and Lidocaine Intramuscular Injections in Terms of Their Efficiency in Decreasing Myofascial Pain within Masseter Muscles: A Randomized, Single-Blind Controlled Trial. Pain Res Manag. 2018 Jun 3;2018:8261090. doi: 10.1155/2018/8261090. eCollection 2018.
- Background: PubMed 34140864Ibrahim NA, Abdel Raoof NA, Mosaad DM, Abu El Kasem ST. Effect of magnesium sulfate iontophoresis on myofascial trigger points in the upper fibres of the trapezius. J Taibah Univ Med Sci. 2021 Jan 19;16(3):369-378. doi: 10.1016/j.jtumed.2020.12.015. eCollection 2021 Jun.
- Individual participant dataSharing planned: Undecided
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Myofacial Pain Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing MgSO4 and BOTOX-A in people with Myofacial Pain and Trigger Points, Myofascial, run by Misr University for Science and Technology at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 12 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mayada Tarek El Menoufy (+2001009006845, Mayadatarek@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluating pain (time frame: preoperative - post operative - 1 , 3 ,6 months follow up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06676475, which also lists 16 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Nov 2024.